Aerospace & Defense
Innovation and collaborative, synchronized program management for new programs
Medical Device Manufacturing is critically dependent on adhering to standards of operational excellence and exceeding FDA compliance requirements at every single stage of the product lifecycles for medical devices. With the health, wellbeing, and even survival of end users at stake, the importance of operational excellence in medical device manufacturing cannot be overstated. However, maintaining those levels of quality in today's market environment becomes very challenging when combined with the competitive need to also increase efficiency, minimize risk, and foster design innovation. To tackle these challenges effectively requires systemic solutions that bolster clarity, traceability, and early-stage error detection across the enterprise.
Complexity in the manufacturing of medical devices (especially for "smart" medical devices that work by using a combination of software and electronics) requires workflows that enable efficient collaboration across inter-disciplinary teams. However, trying to balance compliance management, design requirements, validation testing, etc. without a robust software-platform can quickly become overwhelming. The risk of incomplete or incorrect data can lead to duplicate efforts, quality issues, slower time-to-market, and poor product performance.
Today's med-tech enterprises are commonly made up of geographically distributed research, development, and manufacturing operations facilities. While this kind of structuring can increase a company's access to talent and resources, it also increases the difficulty of executing PLM strategy in a consistent manner. A lack of standardization for document controls, design controls, supplier controls, purchasing controls, production controls, and change controls, greatly increases the risk of errors and delays.
The FDA and other regulatory authorities continue to emphasize mature quality assurance practices over baseline compliance activity. With that in mind, the need for medical device manufacturers to ensure quality and exceed regulatory standards has never been more important. However, a device’s design for manufacturing requirements and its regulatory requirements can evolve throughout the product lifecycle. This can make assurance activities (documentation, filing, testing, etc.) time consuming, complex and extremely costly activities. In order to mitigate the risks of product recalls, slower time-to-market, and even depreciated market endorsement and corporate good will, you need a way to incorporate insight and traceability at every stage in your PLM strategy (i.e. linking compliance requirements with engineering and specification data).